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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

11 New Consumer Advocates to Join Advisory Committees in 2013

The US Food and Drug Administration (FDA) is calling for the nomination of consumer representatives for its public advisory committees.

FDA uses the advisory panels to review high-risk drug products or pressing issues that warrant a transparent discussion of the issues and allow for public comment. Though regulators are free to disregard the final opinions of the committee-and occasionally do, most often when the panel is deeply divided-the committees' opinions often foreshadow FDA's own decisions.

By law, these committees are supposed to be "fairly balanced" to include participation from non-conflicted experts, members of industry and members of the public. The latter two categories are occasionally sought as non-voting members, but are nevertheless influential in their ability to raise questions or points that may alter or influence the course of the committee's discussion.

On 21 February 2013, FDA announced that it is actively seeking 11 members for its advisory committees and their various panels. All eleven are supposed to represent consumer interests, and seven will be given voting privileges on their respective panels. The remaining four will serve in a non-voting capacity.